Effect of COGNI-MACHINE computational thinking training on executive functions in children aged 9 to 11: Protocol of a cluster randomized controlled trial

We designed a controlled trial protocol that seeks to contribute to cognitive science by studying the effect of thought training on children's executive functions. The study design is a cluster randomized controlled trial, with intra-subject and inter-subject evaluation, with two parallel groups: an experimental group and a TAU control group. With three measures, pre-test, post-test, and follow-up after three months. The participants will be children aged 9 to 11. The allocation will be randomized by groups and not individually. The sample will be a minimum of 44 participants. The primary measures will be neuropsychological tests to assess executive functions. Secondary measures will be a computational thinking test, neuropsychological tests to assess metacognition and attention, and an acceptability scale. The experimental group will participate in the COGNI-MACHINE computational thinking training designed by the first author. The training frequency will be twice a week in 60 min sessions for 12 weeks. The TAU control group will receive computer science classes as usual during the same time as the experimental group. The evaluators taking the measurements will be blinded to the assignment. The investigators in charge of the intervention will be blinded to the results of the evaluations.


a b s t r a c t
We designed a controlled trial protocol that seeks to contribute to cognitive science by studying the effect of thought training on children's executive functions.The study design is a cluster randomized controlled trial, with intra-subject and inter-subject evaluation, with two parallel groups: an experimental group and a TAU control group.With three measures, pre-test, post-test, and follow-up after three months.The participants will be children aged 9 to 11.The allocation will be randomized by groups and not individually.The sample will be a minimum of 44 participants.The primary measures will be neuropsychological tests to assess executive functions.Secondary measures will be a computational thinking test, neuropsychological tests to assess metacognition and attention, and an acceptability scale.The experimental group will participate in the COGNI-MACHINE computational thinking training designed by the first author.The training frequency will be twice a week in 60 min sessions for 12 weeks.The TAU control group will receive computer science classes as usual during the same time as the experimental group.The evaluators taking the measurements will be blinded to the assignment.The investigators in charge of the intervention will be blinded to the results of the evaluations.

Specifications table
Subject Area: •

Introduction
Executive functions (EF) constitute a series of high-level cognitive processes regulating thought, action, and emotion underlie flexible goal-directed responses to new or difficult situations [1][2][3] .These cognitive processes depend mainly on the prefrontal areas of the cerebral cortex and their links with other subcortical areas [ 4 ] related to the temporal organization of behavior [ 5 ].The prefrontal cortex has a slow and progressive evolution that begins in childhood and reaches its peak in adulthood [6][7][8][9].This means that the development of executive functions is highly dependent on stimulation throughout the development of the subject and that the first years of life are a critical period for acquiring the basic elements that will enhance executive functions throughout life childhood and adolescence [ 1,[10][11][12].
Computational thinking refers to a particular way of reasoning to solve problems efficiently following the principles of computational sciences [ 52,53 ].It is a set of cognitive processes involved in a particular approach to interpret, analyze and solve problems [ 54 ], which includes: the ability to analyze the problem space, reduce the difficulty of the problem by breaking it down into smaller units, express and represent the solution through algorithms or sequences of instructions, and, finally, correct the execution and verify the scope of the objective [55][56][57][58].
One of the tools to develop computational thinking is teaching programming or coding [ 59 ].Knowing the effects of teaching programming and coding on higher cognitive functions has been another line of study that had its first approaches with authors such as Pea & Kurland [ 60 ], with variable results.You can also find the meta-analyses [61][62][63], which jointly compiled 192 studies and evaluated more than a thousand transfer effects of programming learning in different cognitive processes.These meta-analyses concluded that teaching coding and programming at school ages improves computer skills and other higher-order cognitive processes such as critical thinking, mathematical thinking, creative thinking and metacognition, spatial skills, and reasoning.
In recent years, some studies have evaluated the effects of teaching computational thinking on executive functions in childhood.Some of these studies have found small to large effects on executive functions such as planning, inhibitory control, goal-directed behavior, visuospatial working memory, and other cognitive processes such as sequencing, fluid intelligence, problem-solving, verbal and nonverbal reasoning., mathematical skills, reflective thinking, and creative thinking [ 38,39,43,45,46,49,50,64,65 ].
Even though there are some studies on the subject, these are still scarce, and all the authors conclude on the need to strengthen and expand this field of study to provide feedback to existing intervention programs and impact on public and educational policies [ 46 ].Studying the effects of teaching computational thinking on executive functions and other cognitive processes will allow knowing the impact of study plans and programs aimed at teaching computational thinking, recognizing the most appropriate type of activities concerning the ages of the students and their level of development, the real scope of these initiatives and their differential effect in different periods of cognitive development and different executive functions.

Table 1
Inclusion and exclusion criteria.

Specific objectives and hypotheses
The following randomized controlled trial (RCT) protocol was designed to evaluate the effect of the COGNI-MACHINE computational thinking training program on the executive functions of fifth-grade children aged 9 to 11 years.This RCT has established the following working hypothesis: There are significant differences in the evolution of executive functions and other cognitive processes, such as metacognition and attention, in fifth-grade children who receive training in computational thinking compared to those children who receive a conventional computer training program.

Protocol design
A randomized controlled trial will be conducted by groups, with intra-subject and inter-subject evaluation, with two parallel groups, one experimental and the other in active control with treatment as usual.Three measures will be applied: pre-test, post-test, and follow-up at three months.The clinical trial protocol has been designed following the guidelines of the CONSORT Statement [ 66 ].The trial has been registered in the International Standard Randomized Controlled Trial Number -ISRCTN, a primary clinical trial registry recognized by the World Health Organization, with registration number ISRCTN11380198 and can be consulted at: https://www.isrctn.com/ISRCTN11380198 .Fig. 1 shows the layout of the experimental design.
For the intra-subject analysis, each group will be evaluated before starting the intervention (T1) and after the intervention (T2).Three months after the end of the intervention, a third follow-up measure (T3) will be applied to the experimental group to recognize the permanence of the effect over time.Once the post-test phase is over, the control group will receive the same training in computational thinking.For the intersubject analysis, the study will include an active control group in treatment as usual (Treatment-As-Usual -TAU), which consists of receiving the usual treatment in parallel to the experimental group and for the same time as the experimental group [ 67,68 ].

Inclusion and exclusion criteria
This study will include children in fifth grade of primary school between 9 and 11 years old.Table 1 contains the criteria for including data from children in the controlled trial.

Sample's size calculation
We estimated the size of the groups based on two criteria: (1).A review of previous studies showed a mean group size of 34.8 participants and a median of 26 in similar studies in children [ 30 ]. (2) The G-Power projection suggested a group size of 22 children for a total sample of 44 children.Table 2 contains the parameters for the calculation of the sample.A qualified evaluator outside the research group will be in charge of the evaluation.This evaluator will be blind to the group assignment and the nature of the intervention.

Performance bias Blinding of participants and staff
The evaluator will be blind to the intervention.Since the control group will be treated as usual, blinding among the participating subjects will not be possible Detection bias Blinding of assessors to outcome.
The evaluators will be blind to the type of intervention applied.
The investigator in charge of the intervention will be blinded to the results of the evaluation.

Attrition bias
Incomplete outcome data.Data from participants who complete less than 70% of the training will be excluded from the study.We will perform data imputation; for this, we will evaluate the difference of the results with the data of the excluded subjects and without them.

Reporting bias
Selective reporting of results We will present the results in accordance with the objectives set out in the trial registration.

Recruitment
We evaluated the possible causes of loss from the sample: (1) subjects who did not meet the inclusion factors for the sample, especially the age of the children; (2) dropout rate for this school grade, which is usually around 15%; consequently, for the recruitment we decided to include 4 fifth grade school groups from the same public educational institution in the city of Ibagué, Colombia.Among the four courses, it is expected to convene approximately 100 children, so that the final sample for the analysis has the minimum projected size.

Assignment
The intervention will take place in school contexts, and the sessions will be articulated to curricular work in the area of technology; for this reason, it will be necessary to work with naturally constituted school groups.Consequently, the researchers will not individually assign the subjects to the interventions (Experimental and TAU) but will perform cluster randomization.Studies use cluster randomization in circumstances where individual randomization cannot be achieved, so participants are randomized as groups of individuals or clusters [ 69 ].Randomization will be done by an investigator from outside the study who will assign four sealed envelopes (one for each school group) to each intervention.

Bias control
We used the Cochrane organization's control for bias tool for controlled trials [ 70 ] which covers six bias domains.Table 3 shows the actions established to control the appearance of the most common types of bias in non-clinical studies: selection, detection, performance, performance, desertion and reporting [ 71 ].

Primary outcome measures
To measure the executive functions of children we have selected neuropsychological tests with recognition and reliability studied.Table 4 contains the selected instruments and the rating parameters.

Secondary outcome measures
The study will also include secondary variables such as level of satisfaction with training, computational thinking, metacognition, and attention.Table 5 presents the instruments selected to measure these variables.

Covariate measures
Sociodemographic and participant-specific factors from both groups will be measured and treated as covariates to describe the population and assess the effectiveness of the intervention.The socioeconomic level (SES) will be estimated with the sociodemographic  stratum registry of the National Planning Department (DANE) [ 86 ], and other socioeconomic variables, such as parental education, access to technological means, among others, will be evaluated with the Sociodemographic Characterization Questionnaire [ 87 ].

Interventions Experimental group
The experimental group will participate in a training in computational thinking called COGNI-MACHINE, designed by the first author.The intervention comprises 24 sessions; each session will be structured as a workshop and will take place in the computer room of the participating educational institution.The intervention will last 12 weeks, with two sessions per week of 60 min each.
The training workshops will be based on the principles of problem-based learning, and the activities will be designed following the principles of low floor / high ceiling.For the design of the computational thinking intervention, the following sources were taken into account: (1) The recommendations emerging from the results of the previously conducted pilot test [ 30,45 ]; (2) A broad review of activities, projects, and courses available to teach computational thinking in school contexts; (3) A systematic review of background and similar studies.
To select the plugged and unplugged activities that would be part of the training, we reviewed: (1) Existing open-access training and existing repositories of unplugged activities; (2) The integrated development environments available to learn to code in blocks; 3) The educational robotics devices available in the market for Colombia.From these reviews, unplugged activities were selected   from different sources such as CS Unplugged, code.org,programemos.com,and Mintic's "Coding for kids " [ 88 ].Lessons from courses B, C, and D of the code.orgintegrated development platform and the Makecode integrated development platform were selected for the block programming activities.For the plugged projects, he selected the micro:bit V2 microprocessor (see Fig. 2 ), which is a small programmable board designed by the BBC which has several integrated sensors, Bluetooth connection, radio frequency, push buttons, and LED light outputs.
For the plugged educational robotics activities, an Electricfreaks micro:bit-based robotics kit was selected ( Fig. 3 ), which has a Wukong expansion board, motors, servomotors, additional external sensors (lone-following, ultrasound, toilet level), buildable tiles, among other supplies to develop different types of projects with the micro:bit microprocessor.
Table 6 summarizes the intervention plan, discriminating the intervention phase, the sessions of each phase, the type of activities conducted, and the computational thinking concepts that will be addressed in said sessions based on the proposed framework by Brennan & Resnick [ 89 ].MethodsX 11 (2023) 102329

Control group
The control group at TAU will receive the traditional Technology and Computer Science classes 2 hours a week for 12 weeks.In these classes, students will learn to use Microsoft Office applications.After the 12 weeks of intervention, a crossover design will be conducted so that the control group participates in the same intervention as the experimental group and the experimental group participates in the 12 weeks of traditional technology classes.

Statistical analysis plan
A hypothesis test will be conducted through Mixed Repeated Measures Analysis of Variance (ANOVA MR) with Bonferroni corrections to look at the differences between groups, in which the pre-test, post-test, and follow-up measures will be the factor of repeated measures.(Within-subject) and the difference between the experimental and control groups as the subject factor.The effect size will be measured with partial eta squared.The assumptions of this type of analysis assume a continuous metric-dependent variable with approximately normal distribution and with homoscedasticity in each of the groups.
A multivariate linear regression analysis will also be performed to assess the correlations between cognitive measures and computational thinking.And logistic regressions to analyze binary variables to evaluate the association between the covariates and the results.

Ethical considerations
The study complies with all the ethical requirements described in the Helsinki Declaration and Resolution 8430, which establishes the norms for health research, according to which this study would be classified as without risk [ 90 ].Responding to these parameters, the researchers built informed consent for the parents and guardians and informed assent for the children.These documents will be signed by all the participants who agree to be part of the study.Additionally, a protocol was established with risk minimization actions.This randomized controlled trial has the endorsement of the Bioethics Committee of the University of Tolima registered in Minutes No. 10 of December 13, 2022.

Discussion
Proposing a controlled trial protocol to verify the effects of COGNI-MACHINE computational thinking training on executive functions and other cognitive processes of children in the last years of primary school is relevant for the academic community since it will allow knowing the impact of study plans and programs aimed at teaching computational thinking, recognizing the type of activities that have more acceptability, adherence, and effectiveness in children of this age range as well as recognizing the differential impact that the teaching of computational thinking has on different executive cognitive processes.
One of the main strengths of this study will be the blinding of the evaluators to the allocation and the blinding of the investigators in charge of the intervention to evaluate the subjects.On the other hand, the novelty of the COGNI-MACHINE training, compared to other training, is that it seeks to take advantage of different types of activities to promote computational thinking, not only coding activities.This program includes, on the one hand, disconnected activities to introduce students to the development of more complex and abstract activities.On the other hand, it integrates different types of connected activities, starting with animation activities and game programming in the language of blocks, to later develop robotics projects applied to problem-solving.
One of the study's limitations is that, since the application context is school and integrated into the technology curricular program, individual randomization of the participants will not be possible.Therefore, the randomization will be conducted by groups.Additionally, given the nature of the study, participants will not be blinded to the intervention.
Cognitive sciences More specific subject area: • Children's Cognitive Development Protocol name: Effect of COGNI-MACHINE computational thinking training on executive functions in children aged 9 to 11: Protocol of a Cluster Randomized Controlled Trial Reagents/tools: • Cogni-Machine computational thinking training • Micro:bit based robotics kit • Code.orgcourses ( continued on next page )

1 . 4 .
Children of both sexes.1. Children with uncorrected sensory impairment.2. Children who at the time of the beginning the study are between 9 and 11 years old.2. Children with a psychiatric diagnosis.3. Children enrolled in fifth grade of primary school in an educational institution of Ibagué, Colombia.3. Children who exceed the age range at the beginning of the pre-test.Children with typical cognitive development.4. Children with previous experience in computational thinking, coding or programming training.5. Children who have participated in 70% of the intervention.5. Children who have joined the educational institution after the application of the pretest.

Fig. 3 .
Fig. 3. Example of educational robotics projects in micro:bit with the Electricfreaks robotics kit.

Table 2
Parameters for the size of the groups.

Table 3
Cochrane risk of bias check tool.

Table 4
Description of primary measures.

Table 5
Description of secondary measures.

Table 6
Summary of intervention sessions.